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NCT00700661 Clinical Trial

A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907)

Asthma Clinical Trial

Official title:
A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Study to Determine the Efficacy of Montelukast in the Treatment of Exacerbations in Asthmatic Patients Aged 2-to-5 Years

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00700661
Other study ID # 0476-907
Secondary ID MK0476-9072007_5
Status Completed
Phase Phase 3
First received
Last updated
Start date January 2001
Est. completion date December 2002

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date December 2002
Est. primary completion date December 2002
Accepts healthy volunteers No
Gender All
Age group 2 Years to 5 Years
Eligibility Inclusion Criteria: - Male or Female between and including the ages of 2 and 5 years - Patient was treated with steroids for an asthma episode in the last 3 months - Patient was admitted to the hospital or emergency room in the last 3 months - Patient is able to chew a tablet Exclusion Criteria: - Patient has been in a research study in the past 4 weeks - Patient has visited the emergency room for an asthma episode in the past week - Patients has a history of stomach, heart, liver, nerve, kidney or blood disease

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• montelukast
One montelukast 4-mg chewable tablet (CT) administered once daily at bedtime. Duration of Treatment: 48 Weeks
• placebo (unspecified)
Matching-image Montelukast placebo. Duration of Treatment: 48 Weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

Bisgaard H, Zielen S, Garcia-Garcia ML, Johnston SL, Gilles L, Menten J, Tozzi CA, Polos P. Montelukast reduces asthma exacerbations in 2- to 5-year-old children with intermittent asthma. Am J Respir Crit Care Med. 2005 Feb 15;171(4):315-22. Epub 2004 Nov 12. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary asthma episodes in 2 - 5 year old children at 12 months
Secondary the number of treatments and duration of asthma episodes at 12 months
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